XP13512 (GSK1838262) Versus Placebo in Patients With Restless Legs Syndrome.

This study has been completed.
Sponsor:
Information provided by:
XenoPort, Inc.
ClinicalTrials.gov Identifier:
NCT00298623
First received: February 28, 2006
Last updated: May 10, 2013
Last verified: May 2011

February 28, 2006
May 10, 2013
March 2006
February 2007   (final data collection date for primary outcome measure)
  • The change from baseline to the end of treatment in International Restless Legs Syndrome (IRLS) rating scale score. [ Time Frame: 12-week treatment period ] [ Designated as safety issue: No ]
  • The proportion of subjects at the end of treatment who are "much improved" or "very much improved" on the Investigator-rated CGI of Improvement [ Time Frame: 12-week treatment period ] [ Designated as safety issue: No ]
The change from baseline to the end of treatment in IRLS rating scale score. The proportion of patients at the end of treatment who are "much improved" or "very much improved" on the Investigator-rated CGI of Change.
Complete list of historical versions of study NCT00298623 on ClinicalTrials.gov Archive Site
Onset of efficacy. Subjective measures of sleep. [ Time Frame: 12-week treatment period ] [ Designated as safety issue: No ]
Onset of efficacy. Subjective measures of sleep.
Not Provided
Not Provided
 
XP13512 (GSK1838262) Versus Placebo in Patients With Restless Legs Syndrome.
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of XP13512 in Patients With Restless Legs Syndrome.

The primary objective of this trial is to assess the efficacy of XP13512 taken once daily compared to placebo for the treatment of patients suffering from Restless Legs Syndrome (RLS).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Restless Legs Syndrome
  • Drug: XP13512 (GSK1838262)
  • Other: placebo
  • Placebo Comparator: Placebo
    Intervention: Other: placebo
  • Experimental: XP13512 (GSK1838262)
    Intervention: Drug: XP13512 (GSK1838262)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
222
February 2007
February 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with primary RLS, based on the International RLS Study Group Diagnostic Criteria.
  • History of RLS symptoms at least 15 nights in the prior month or, if on treatment, this frequency of symptoms before treatment was started;
  • Documented RLS symptoms for at least 4 of the 7 consecutive evenings/nights during the Baseline study period;
  • Total RLS severity score of 15 or greater on the International Restless Legs Syndrome Study Group Rating Scale (IRLS rating scale) at Visit 1 and at Visit 2;
  • Discontinuation of dopamine agonists and/or gabapentin at least 2 weeks prior to Baseline;
  • Discontinuation of other treatments for RLS (e.g., opioids, benzodiazepines) at least 2 weeks prior to Baseline;
  • If female of child-bearing potential, the subject must agree to use clinically accepted birth control through completion of the study;
  • Body Mass Index of 34 or below;
  • Estimated creatinine clearance of at least 60 mL/min;

Exclusion Criteria:

  • A sleep disorder (e.g., sleep apnea) that may significantly affect the assessment of RLS;
  • Neurologic disease or movement disorder (e.g., diabetic neuropathy, Parkinson's Disease, Multiple Sclerosis, dyskinesias, and dystonias);
  • Abnormal laboratory results, electrocardiogram (ECG) or physical findings;
  • Pregnant or lactating women;
  • Women of childbearing potential who are not practicing an acceptable method of birth control.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00298623
110963
Yes
Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
XenoPort, Inc.
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
XenoPort, Inc.
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP